Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Procedural Pain Clinical Trial

Official title:

Virtual Reality for Alleviation of Peripheral IV Placement-Associated Discomfort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03740607
• Other study ID #: c.2017.114d
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: September 15, 2022

Study information

• Verified date: August 2021
• Source: Brooke Army Medical Center
• Contact: Annie L Chow, MD, MPH, MS
• Phone: 6093063329
• Email: chowanni[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Immersive virtual reality (iVR) has been used successfully to manage pain with distraction. It is a non-invasive treatment modality unassociated with worrisome well-known side effects typically seen when opioids and NSAIDS are used, and has previously been used safely in place of analgesia during dressing changes and burn care. This study investigates whether iVR can be useful as a stand-alone option to manage the pain associated with placement of peripheral intravenous (PIV) catheters in adults.

Description:

This is a prospective study of the effect of immersive virtual reality on the perception of pain during peripheral IV (PIV) placement. Adult patients who require PIV placement for elective surgery will be consented for intervention while in the peri-operative suites (PS). The VR intervention will consist of a headset and immersive VR software that allows the patient to engage in a virtual world during PIV placement. Subjects will be queried immediately after PIV placement using the validated graphic rating scale regarding the sensory, cognitive, and affective aspects of discomfort they experienced with PIV placement (Appendix A). They will also be asked two validated questions concerning patient satisfaction (Dexter et al 1997). A control group of patients will undergo a similar assessment with slightly different wording after receiving PIV placement without iVR.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 15, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

Inclusion Criteria:

Brooke Army Medical Center patients age 19-89 undergoing peripheral intravenous catheter placement in preparation for elective surgery will be eligible for participation.

Exclusion Criteria:

Patients will be excluded with head wounds/head bandages preventing the use of a headset, active nausea/vomiting, history of seizure, dementia, psychosis, mania, vertigo, or motion sickness, if the patient is pregnant or incarcerated on the day of surgery, and if the patient is unable to consent self.

Related Conditions & MeSH terms

• Pain, Procedural
• Perioperative Care
• Procedural Anxiety
• Procedural Pain

Intervention

Device:
• Virtual reality
Healthcare virtual reality software implemented during peripheral intravenous catheter placement

Procedure:
• Peripheral intravenous catheter placement
Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.

Locations

Country	Name	City	State
United States	Brooke Army Medical Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Brooke Army Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (11)

Dexter F, Aker J, Wright WA. Development of a measure of patient satisfaction with monitored anesthesia care: the Iowa Satisfaction with Anesthesia Scale. Anesthesiology. 1997 Oct;87(4):865-73. — View Citation

Gold JI, Kim SH, Kant AJ, Joseph MH, Rizzo AS. Effectiveness of virtual reality for pediatric pain distraction during i.v. placement. Cyberpsychol Behav. 2006 Apr;9(2):207-12. — View Citation

Hoffman HG, Patterson DR, Seibel E, Soltani M, Jewett-Leahy L, Sharar SR. Virtual reality pain control during burn wound debridement in the hydrotank. Clin J Pain. 2008 May;24(4):299-304. doi: 10.1097/AJP.0b013e318164d2cc. — View Citation

Hoffman HG, Richards TL, Van Oostrom T, Coda BA, Jensen MP, Blough DK, Sharar SR. The analgesic effects of opioids and immersive virtual reality distraction: evidence from subjective and functional brain imaging assessments. Anesth Analg. 2007 Dec;105(6):1776-83, table of contents. — View Citation

Indovina P, Barone D, Gallo L, Chirico A, De Pietro G, Giordano A. Virtual Reality as a Distraction Intervention to Relieve Pain and Distress During Medical Procedures: A Comprehensive Literature Review. Clin J Pain. 2018 Sep;34(9):858-877. doi: 10.1097/AJP.0000000000000599. Review. — View Citation

Kenney MP, Milling LS. The effectiveness of virtual reality distraction for reducing pain: a meta-analysis. Psychology of Consciousness: Theory, Research, and Practice 3(3): 199-210, 2016.

Maani CV, Hoffman HG, Fowler M, Maiers AJ, Gaylord KM, Desocio PA. Combining ketamine and virtual reality pain control during severe burn wound care: one military and one civilian patient. Pain Med. 2011 Apr;12(4):673-8. doi: 10.1111/j.1526-4637.2011.01091.x. Epub 2011 Apr 11. — View Citation

Maani CV, Hoffman HG, Morrow M, Maiers A, Gaylord K, McGhee LL, DeSocio PA. Virtual reality pain control during burn wound debridement of combat-related burn injuries using robot-like arm mounted VR goggles. J Trauma. 2011 Jul;71(1 Suppl):S125-30. doi: 10.1097/TA.0b013e31822192e2. — View Citation

Malloy KM, Milling LS. The effectiveness of virtual reality distraction for pain reduction: a systematic review. Clin Psychol Rev. 2010 Dec;30(8):1011-8. doi: 10.1016/j.cpr.2010.07.001. Epub 2010 Jul 13. Review. — View Citation

Rosen LD, Whaling K, Carrier LM, Cheever NA, Rokkum J. The Media and Technology Usage and Attitudes Scale: An empirical investigation. Comput Human Behav. 2013 Nov 1;29(6):2501-2511. — View Citation

Tashjian VC, Mosadeghi S, Howard AR, Lopez M, Dupuy T, Reid M, Martinez B, Ahmed S, Dailey F, Robbins K, Rosen B, Fuller G, Danovitch I, IsHak W, Spiegel B. Virtual Reality for Management of Pain in Hospitalized Patients: Results of a Controlled Trial. JMIR Ment Health. 2017 Mar 29;4(1):e9. doi: 10.2196/mental.7387. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discomfort associated with peripheral IV placement	Subject experiences will be measured using a validated graphic rating scale (GRS) which enquires about the extent to which the experience was unpleasant.	This outcome will be measured immediately after peripheral IV placement
Secondary	Magnitude of pain severity	Subjects will rate their worst pain during the IV placement on a scale of 1-10 out of 10 possible points	This outcome will be measured immediately after peripheral IV placement
Secondary	Time spent thinking about pain	Subject will describe the amount of time spent thinking about pain during IV placement, as a proportion.	This outcome will be measured immediately after peripheral IV placement
Secondary	Degree to which subject felt immersed in virtual reality	The subject will answer a question regarding the extent to which they felt they went "inside" the computer-generated world	This outcome will be measured immediately after peripheral IV placement
Secondary	Nausea	Subject will answer a question regarding extent to which nausea was experienced during IV placement	This outcome will be measured immediately after peripheral IV placement
Secondary	Claustrophobia	The subject will be asked to answer a question about the extent to which they felt claustrophobic for any reason during IV placement	This outcome will be measured immediately after peripheral IV placement
Secondary	Clinical significance	the subject will be asked if they would want to have their IV placed this way again	This outcome will be measured immediately after peripheral IV placement
Secondary	Satisfaction score	The subject will be asked if they were satisfied with IV placement	This outcome will be measured immediately after peripheral IV placement
Secondary	Physiological parameters	Baseline vital signs- continuous variables	Initial vital signs at start of anesthesia care will be abstracted retrospectively. This reading will likely occur within an hour of the initial intervention, as start times for anesthesia cases are within an hour of initiation of peri-operative care
Secondary	Fun factor	Subject will describe the extent to which they found the experience to be fun, on a scale of 1-10	This outcome will be measured immediately after peripheral IV placement